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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002793
Receipt No. R000003279
Scientific Title Translational research regarding the effect of TS-1 on CECs from metastatic or relapsed breast cancer patients.
Date of disclosure of the study information 2009/12/01
Last modified on 2013/11/25

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Basic information
Public title Translational research regarding the effect of TS-1 on CECs from metastatic or relapsed breast cancer patients.
Acronym Translational research regarding the effect of TS-1 on CECs.
Scientific Title Translational research regarding the effect of TS-1 on CECs from metastatic or relapsed breast cancer patients.
Scientific Title:Acronym Translational research regarding the effect of TS-1 on CECs.
Region
Japan

Condition
Condition metastatic or relapsed breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The effect of TS-1 on circulating endothelial cells.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To assess the changes of CECs or CEPs from the patients treated with TS-1.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Internal use of TS-1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1)
Key exclusion criteria 1)
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Toi
Organization Kyoto University Hospital
Division name Breast Surgery Department
Zip code
Address 54 kawara-cho shogoin sakyo-ku kyoto city, Japan
TEL 075-751-3660
Email

Public contact
Name of contact person
1st name
Middle name
Last name Wakako Tsuji
Organization Kyoto University Hospital
Division name Breast Surgery Department
Zip code
Address 54 kawara-cho shogoin sakyo-ku kyoto city, Japan
TEL 075-751-3660
Homepage URL
Email w-sato@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital, Breast Surgery Department
Institute
Department

Funding Source
Organization Taiho Phamaceutical Company
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 京都大学医学部附属病院(京都府)、天理よろづ相談所病院(奈良県)、田附興風会医学研究所北野病院(大阪府)、三菱京都病院(京都府)、公立甲賀病院(滋賀県)、彦根市立病院(滋賀県)

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 11 Month 24 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 24 Day
Last modified on
2013 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003279

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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